IMLYGIC Solution for injection Ref.[7652] Active ingredients: Talimogene laherparepvec

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands

Product name and form

Imlygic 106 plaque forming units (PFU)/mL solution for injection.

Imlygic 108 plaque forming units (PFU)/mL solution for injection.

Pharmaceutical Form

Solution for injection.

Imlygic 106 plaque forming units (PFU)/mL solution for injection: Clear to semi-translucent liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles.

Imlygic 108 plaque forming units (PFU)/mL solution for injection: Semi-translucent to opaque liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles.

Qualitative and quantitative composition

Talimogene laherparepvec is an attenuated herpes simplex virus type-1 (HSV-1) derived by functional deletion of 2 genes (ICP34.5 and ICP47) and insertion of coding sequence for human granulocyte macrophage colony-stimulating factor (GM-CSF) (see section 5.1).

Talimogene laherparepvec is produced in Vero cells by recombinant DNA technology.

Imlygic 10 6 plaque forming units (PFU)/mL solution for injection: Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 × 106 (1 million) plaque forming units (PFU)/mL.

Imlygic 10 8 plaque forming units (PFU)/mL solution for injection: Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 × 108 (100 million) plaque forming units (PFU)/mL.

Excipient with known effect: Each 4 mL dose contains approximately 30 mg (1.3 mmol) sodium and 80 mg sorbitol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Talimogene laherparepvec

Talimogene laherparepvec is an oncolytic immunotherapy that is derived from HSV-1. Talimogene laherparepvec has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF. Talimogene laherparepvec causes the death of tumour cells and the release of tumour-derived antigens.

List of Excipients

Di-sodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Sodium chloride
Myo-inositol
Sorbitol (E420)
Water for injections

Pack sizes and marketing

Imlygic is provided as a one ml preservative-free solution in a single–use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene) in two different presentations:

Figure 6. Single-use vial permanently inserted into a clear copolyester plastic sleeve:

OR

Figure 7. Single-use vial without a clear plastic sleeve:

The vial cap is colour coded: 106 (1 million) PFU/mL is light green and 108 (100 million) PFU/mL is royal blue.

Marketing authorization holder

Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands

Marketing authorization dates and numbers

EU/1/15/1064/001

EU/1/15/1064/002

Date of first authorisation: 16 December 2015

Drugs

Drug Countries
IMLYGIC Austria, Estonia, Finland, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom, United States

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